- Elekta, Inc. v. Varian Medical Systems, Inc.All claims unpatentablePTAB · Dec 23, 2016 · IPR2015-01401 · APJ Garth D Baer · IPR · Final written decision
Claims 1, 4–7, 14, 15, 53, 60, and 61 are unpatentable over Jaffray 2001 under §§ 102(b) and 103(a), and over the stated Jaffray combinations under § 103(a).
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question” at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). We construe only those claim terms necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). 2. “capable of implementing a treatment plan” Patent Owner takes the position that to be “capable of implementing a treatment plan,” a radiation treatment system cannot still be in development and must pass industry-established quality assurance validations that are prerequisites to commissioning such systems for use on real patients. See PO Resp. 17–18. We decline to read in these additional limitations. Neither the claims nor the Specification has any support for excluding devices that are still early in development, or those that have not yet been validated against established quality standards. The broadest reasonable construction of the term requires no more than a system capable of implementing one or more treatment plans. 3. “communications network” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Patent Owner asserts “[a] communications network is a communication system that facilitates communication between many devices and that uses a networking protocol to selectively route messages to their intended devices.” PO Resp. 28. In Reply, Petitioner proposes a broader construction: “a link between two or more components of the radiation treatment system that allows information to be shared between them.” Reply 11. We agree with Petitioner. In the three instances when the ’021 patent Specification recites “communications network,” it describes only a generic connection between components. See Ex. 1001, 2:36–40 (explaining that “[t]he couch 218 may be connected to the therapy simulator rotatable gantry via a communications network”), 4:16–18 (explaining that “the computer 220 connects to the simulator 100 and the command processor 225 via a communications network 240”), 6:16–18 (explaining that “box 451, processor 425, and computer 450 connect to simulator 400 via communications network 440”). Figures 1 and 3 of the ’021 patent depict the communications network (items 240 and 440) simply as arrows connecting various components. Notably absent from the ’021 patent is any reference to networking protocols or a routing mechanism, and nothing in the term’s plain language requires a networking protocol or selectively routing messages as Patent Owner suggests. We agree with Petitioner under the broadest reasonable construction, a communications network is simply a link between two or more components of the radiation treatment system that allows information to be shared between them. 4. “a high energy radiation source” and “a cone-beam radiation source”” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“i. Jaffray 2001 Teaches “a radiation treatment system capable of implementing a treatment plan” All of the challenged claims require a “radiation treatment system capable of implementing a treatment plan.” We agree with Petitioner that because Jaffray 2001 teaches “[t]he adaptation of this system to a medical linear accelerator for on-line image-guided radiation therapy demonstrates the suitability of this technology for intra-therapeutic guidance,” Jaffray 2001 discloses a system capable of implementing a treatment plan. See Pet. 18 (quoting Ex. 1003, 800); Ex. 2024 ¶¶ 25–28 (explaining that “a medical linear accelerator, by its very nature, is capable of implementing a treatment plan”), ¶¶ 29–30 (explaining that Fig. 2(a) from Patent Owner’s Exhibit 2015 confirms that Jaffray 2001’s medical linear accelerator is capable of implementing a treatment plan). In contesting this element, Patent Owner notes that one of the other Jaffray references—Jaffray JRO 1999 (Ex. 1007)—states its design “allows normal operation of the accelerator with the imagers removed and the kV xray tube retracted.” Ex. 1007, 775. Patent Owner interprets Jaffray JRO 1999’s statement to mean in all of Jaffray’s systems, removing the imaging system was “necessary” before the linear accelerator could implement a treatment plan. PO Resp. 8–9; Ex. 2020 ¶ 58. Patent Owner argues further Jaffray 2001’s system was not capable of implementing a treatment plan because it was still in development and had not been tested or validated against established industry standards that must be met before the FDA will commission such devices for medical use. See PO Resp.17–18; Ex. 2020 ¶¶ 49–52. We disagree. As explained above, under our claim construction, the claim limitation at issue requires only a system capable of implementing one or more treatment plans, not one that is ready to certify for actual medical use on real patients. Jaffray JRO 1999’s reference to allowing normal operation with the imagers removed does not undermine that teaching; it simply indicates the disclosed system permits radiation therapy with the imagers removed, a feature beneficial for “limited situations in which the treatment plan may require extreme angulation.” Reply 3; see Ex. 1024 ¶¶ 7–8. We find Jaffray 2001 discloses a radiation treatment system capable of implementing a treatment plan as the challenged claims require.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“challenged claims, the claimed subject matter would have been obvious over Jaffray 2001 at the time of the invention. See Pet. 26–27. As explained above, we find Jaffray 2001 discloses every limitation from the challenged claims. In addition, Petitioner explains—with unrefuted support from Dr. Hamilton and the prior art—by 1981 translatable treatment couches moveable in three planes plus angulation and coupled to the gantry via a communications network were standard on linear accelerators. See Pet. 26– 27 (citing Ex. 1016 ¶ 36; Ex. 1015, 220; Ex. 1010, 1, 2, 12, 39–48). Petitioner also explains—again with unrefuted support from Dr. Hamilton— none of the Jaffray references suggest any changes to these standard features and one skilled in the art would understand the linear accelerator depicted in Jaffray 2001 is the Elekta SL20, which had a translatable treatment couch including the same standard features. Pet. 27 (citing Ex. 1016 ¶ 128). In addition, Petitioner explains that to the extent Jaffray 2001 fails to disclose a computing unit to capture and store image projection data, it would have been obvious to one skilled in the art to include one because “to process the image projection data to generate volumetric images, it is necessary to store the image projection data in the computer which will process the data.” Pet. 27 (citing 1016 ¶ 207). Thus, in addition to demonstrating the necessary disclosures in the prior art (through incorporating its anticipation argument), Petitioner identified sufficient reasons that would have prompted a person of ordinary skill in the relevant field to combine the elements the way the claimed invention does. See KSR, 550 U.S. at 418. In contesting obviousness based on Jaffray 2001, Patent Owner reiterates its argument that Jaffray 2001 does not disclose a system capable of implementing a treatment plan (as required in all of the challenged claims), a computing unit coupled to the rotatable gantry via a communications network (as required in claims 1, 4, and 5), or a translatable treatment couch coupled to the rotatable gantry via a communications network (as required in claims 14, 15, and 60). PO Resp. 45. Patent Owner asserts also we should reject Petitioner’s obviousness challenge as an improper attempt to “bootstrap” obviousness to anticipation, without identifying any differences between the claimed subject matter and the prior art or explaining why those elements would have been obvious to a person of ordinary skill in the art. Id. at 43. We disagree with Patent Owner’s arguments addressing Jaffray 2001’s ability to implement a treatment plan and communications network for the reasons explained in our anticipation analysis above. Moreover, we do not view Petitioner’s obviousness challenge as a mere “bootstrap” to anticipation because Petitioner identified potential differences between Jaffray 2001 and claimed subject matter (i.e., the claimed translatable treatment couch and computing unit to store image projection data) as well as rationale explaining why one skilled in the art would have known to include those elements.” slip op. at 19
Patent outcomesUS 7,945,021 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,945,021 - Infobionic, Inc. v. Braemar Manufacturing, LLCInstitution deniedPTAB · Dec 23, 2016 · IPR2016-01237 · APJ Ken B Barrett · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that claims 1–44 would have been obvious over Baker, Xu, and Hatke.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review of U.S. Patent No. 7,212,850 B2 (“the ’850 patent”). Paper 2 (“Pet.”). The Petition challenges the patentability of claims 1–44 of the ’850 patent on the grounds of obviousness under 35 U.S.C. § 103. Braemar Manufacturing, LLC (Patent Owner) filed a Preliminary Response to the Petition. Paper 7 (“Prelim. Resp.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the information presented in the Petition, we determine that Petitioner has not established a reasonable likelihood that it would prevail with respect to any of the claims challenged in the Petition. Accordingly, we do not authorize an inter partes review to be instituted as to any challenged claim of the ’850 patent.” slip op. at 2
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). Further, a patent claim composed of several elements is not proved obvious merely by demonstrating that each of its elements was known, independently, in the prior art. Id. at 418. Additionally, we determine Petitioner—by, inter alia, ambiguously referring to disclosures in multiple references individually and in combination—has failed to explain adequately how it is proposing to combine or modify the references’ teachings to arrive at the claimed subject matter of the forty-four challenged claims. See, e.g., Pet. 29 (“Baker or Xu alone, as well as in combination, disclose the broader claim feature and the narrower feature in claims 35 and 41.”) For these reasons, we determine Petitioner has not demonstrated there is a reasonable likelihood of establishing the unpatentability of the challenged claims.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“display of Hatke’s Figure 6 is “strikingly similar” to that of Figures 2 and 4 of the ’850 patent, with Hatke’s “detected events on top of the trend data instead of below it.” Pet. 43–44. We determine that Petitioner’s argument is insufficient because it primarily relies on the purported similarity in appearance of the figures and fails to articulate sufficiently how the prior art suggests the claim limitation. We also agree with Patent Owner that this use of the ’850 patent hints at hindsight. See Prelim. Resp. 31 (“Aside from a desire to recreate Figure 2 of the ’850 patent, Petitioner fails to explain why the skilled person would have wanted to do this.”). Additionally, we disagree with Petitioner’s assertion that Hatke’s figure is “strikingly similar” to that of the ’850 patent. At most, Hatke’s oxyhemoglobin saturation data has an I-beam shape like that of the ’850 patent’s heart rate. However, Hatke’s histogram showing the quantity of apnea events does not have the appearance of AF burden. Rather, Petitioner is forced to look to a separate figure in Hatke, Figure 7, to find what Petitioner calls “blocks” similar to those of the ’850 patent. Id. at 45–46. Petitioner then proposes modifying Hatke’s Figure 6 by “dumbing [it] down,” apparently proposing to convert the quantities of apnea events to blocks depicting apnea event duration, reasoning that drawing a line for time span was a well-known and intuitive technique to depict time span. Id. at 46; see also id. at 49 (Petitioner impliedly arguing that displaying AF burden merely is drawing AF event time spans as a line). We do not find this persuasive because the fact that one could depict duration as a line does not explain adequately why one would modify Figure 6, even in the context of apnea events. Further, even were we to accept that it first would have been obvious to modify a display related to sleep apnea to arrive at Petitioner’s proposed modified Figure 6, Petitioner fails to explain persuasively why one would have utilized that proposed modified display—which would show oxyhemoglobin saturation and respiratory effort—as the format to display heart rate and AF burden. Mere similarity of appearance—particularly assuming, as we must, that one of ordinary skill lacks the knowledge of the figures of the ’850 patent—does not point towards an eventual conclusion of obviousness of the claimed subject matter.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightTeaching away not foundNot shown unpatentable
“display of Hatke’s Figure 6 is “strikingly similar” to that of Figures 2 and 4 of the ’850 patent, with Hatke’s “detected events on top of the trend data instead of below it.” Pet. 43–44. We determine that Petitioner’s argument is insufficient because it primarily relies on the purported similarity in appearance of the figures and fails to articulate sufficiently how the prior art suggests the claim limitation. We also agree with Patent Owner that this use of the ’850 patent hints at hindsight. See Prelim. Resp. 31 (“Aside from a desire to recreate Figure 2 of the ’850 patent, Petitioner fails to explain why the skilled person would have wanted to do this.”). Additionally, we disagree with Petitioner’s assertion that Hatke’s figure is “strikingly similar” to that of the ’850 patent. At most, Hatke’s oxyhemoglobin saturation data has an I-beam shape like that of the ’850 patent’s heart rate. However, Hatke’s histogram showing the quantity of apnea events does not have the appearance of AF burden. Rather, Petitioner is forced to look to a separate figure in Hatke, Figure 7, to find what Petitioner calls “blocks” similar to those of the ’850 patent. Id. at 45–46. Petitioner then proposes modifying Hatke’s Figure 6 by “dumbing [it] down,” apparently proposing to convert the quantities of apnea events to blocks depicting apnea event duration, reasoning that drawing a line for time span was a well-known and intuitive technique to depict time span. Id. at 46; see also id. at 49 (Petitioner impliedly arguing that displaying AF burden merely is drawing AF event time spans as a line). We do not find this persuasive because the fact that one could depict duration as a line does not explain adequately why one would modify Figure 6, even in the context of apnea events. Further, even were we to accept that it first would have been obvious to modify a display related to sleep apnea to arrive at Petitioner’s proposed modified Figure 6, Petitioner fails to explain persuasively why one would have utilized that proposed modified display—which would show oxyhemoglobin saturation and respiratory effort—as the format to display heart rate and AF burden. Mere similarity of appearance—particularly assuming, as we must, that one of ordinary skill lacks the knowledge of the figures of the ’850 patent—does not point towards an eventual conclusion of obviousness of the claimed subject matter.” slip op. at 13
§ 103 obviousnesscites KSRPatents in suitUS 7,212,850 - Infobionic, Inc. v. Braemar Manufacturing, LLCInstitution deniedPTAB · Dec 23, 2016 · IPR2016-01236 · APJ Ken B Barrett · IPR · Institution
The Board denied institution on all challenged claims 1–28 because Petitioner did not show a reasonable likelihood that the claims were obvious over Baker, Xu, and Hatke.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“limitation would have been obvious in view of the combination of Baker, Xu, and Hatke.”); id. at 26 (“Baker or Xu alone, as well as in combination, disclose the first claim limitation of independent claim 1 and 12.”). A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). Further, a patent claim composed of several elements is not proved obvious merely by demonstrating that each of its elements was known, independently, in the prior art. Id. at 418. Petitioner’s discussion of the “subset” feature is an example of a flawed analysis focused on individual elements rather than an ordered whole. Petitioner’s rationale for the combining of Baker and Xu is that Xu “provid[es] an efficient and accurate AF detection algorithm” (Pet. 24) and “because [Xu’s algorithm] has the desirable characteristics of rapidly and accurately detecting AF events with robust anti-noise performance and requires a short amount of computing time” (id. at 31). Although it is not clear as to how Petitioner proposes to modify Baker by Xu, it appears that Petitioner may be proposing to substitute that efficient, rapid, and accurate algorithm into Baker’s system. Xu’s algorithm is efficient and accurate when it is “ready to use.” See Pet. 21. According to Petitioner (see id.), human assessment ceases before the algorithm becomes “ready to use” because human assessment is used only to “train up” the algorithm. Accordingly, the use of Xu’s system, after having been trained up and ready to use, would not involve human assessment of any subset of events identified by the system. Thus, Petitioner’s identification of a “subset” as being that data apparently the subject of one hundred percent human review prior to being “ready to use” (Pet. 40) is inconsistent with Petitioner’s reason why one would have combined Baker and Xu. Further, Petitioner’s style of addressing claim terms in a vacuum leaves us unable to determine whether Petitioner has demonstrated a likelihood of proving the claimed subject matter as a whole would have been obvious. It is not enough for Petitioner to assert that one or more references disclose a human assessment of a subset of data. See Prelim. Resp. 40. In claim 1, for example, the “subset” is of the “identified AF events,” which ties the subset to the limitation directed to identifying AF events and to the “pictographically presenting” limitation, which is based on the human assessment of the subset of the identified AF events. Petitioner does not adequately explain why or how the three relied-upon references would have been combined or modified such that all of the limitations of the claimed subject matter would have been satisfied at the same time in the same related manner as in the claims. Accordingly, Petitioner does not persuasively articulate an adequate reason why and how the teachings of the three reliedupon references would have rendered obvious the claimed subject matter as a whole.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“display of Hatke’s Figure 6 is “strikingly similar” to that of Figures 2 and 4 of the ’996 patent, with Hatke’s “detected events on top of the trend data instead of below it.” Pet. 41–42. We determine that Petitioner’s argument is insufficient because it primarily relies on the purported similarity in appearance of the figures and fails to articulate sufficiently how the prior art suggests the claim limitation. We also agree with Patent Owner that this use of the ’996 patent hints at hindsight. See Prelim. Resp. 29 (“Aside from a desire to recreate Figure 2 of the ’996 patent, Petitioner fails to explain why the skilled person would have wanted to do this.”). Additionally, we disagree with Petitioner’s assertion that Hatke’s figure is “strikingly similar” to that of the ’996 patent. At most, Hatke’s oxyhemoglobin saturation data has an I-beam shape like that of the ’996 patent’s heart rate. However, Hatke’s histogram showing the quantity of apnea events does not have the appearance of AF burden. Rather, Petitioner is forced to look to a separate figure in Hatke, Figure 7, to find what Petitioner calls “blocks” similar to those of the ’996 patent. Id. at 43–44. Petitioner then proposes modifying Hatke’s Figure 6 by “dumbing [it] down,” apparently proposing to convert the quantities of apnea events to blocks depicting apnea event duration, reasoning that drawing a line for time span was a well-known and intuitive technique to depict time span. Id. at 44; see also id. at 46 (Petitioner impliedly arguing that displaying AF burden merely is drawing AF event time spans as a line). We do not find this persuasive because the fact that one could depict duration as a line does not explain adequately why one would modify Figure 6, even in the context of apnea events. Further, even were we to accept that it first would have been obvious to modify a display related to sleep apnea to arrive at Petitioner’s proposed modified Figure 6, Petitioner fails to explain persuasively why one would have utilized that proposed modified display—which would show oxyhemoglobin saturation and respiratory effort—as the format to display heart rate and AF burden. Mere similarity of appearance—particularly assuming, as we must, that one of ordinary skill lacks the knowledge of the figures of the ’996 patent—does not point towards an eventual conclusion of obviousness of the claimed subject matter.” slip op. at 9
§ 103 obviousnesscites KSRPatents in suitUS 7,907,996 - PTAB · Dec 22, 2016 · IPR2015-00554 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Jazz Pharmaceuticals’ rehearing request, leaving intact its determination that claims 1–11 are unpatentable as obvious over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Expert testimonyDecided for patent owner
“and 9; Ex. 2044, 181:1–23; Ex. 2046 ¶¶ 45–49). Though we did not discuss the expert testimony, we considered it. For example, on the same page of testimony cited by Patent Owner, Dr. Valuck testified that the information sufficient to identify a patient is “whatever the pharmacist believes is required to sufficiently identify the patient in their professional judgment.” Ex. 2044, 98:2–16. Even so, our Decision puts primary emphasis on the claim language and relevant description of the “identifying” element in the specification, not the extrinsic expert testimony relied upon by Patent Owner. See Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1012–13 (Fed. Cir. 2016) (“The legal part of claim construction is the determination of the meaning of the term in the claim in light of the patent’s intrinsic record.”); see also Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (stating that sources outside the specification should not be “used to contradict claim meaning that is unambiguous in light of the intrinsic evidence.”).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“We made clear that the controlling description of the specification outweighed Patent Owner’s argument and supporting evidence that specific types of information are required to be read into the “identifying” element of the claims. Id. (“Thus, we construe ‘prescription requests [for GHB] containing information identifying patients’ to refer to information identifying a patient, which may include [Patent Owner’s specifically listed information], but is not limited to that information nor requires all of that information.”) (emphasis added). We also cited to all of the expert testimony on which Patent Owner relied for its claim construction, as an indication that we considered the testimony. Id. at 18 (citing Ex. 2044, 97:11–98:5, 99:18–100:10; Ex. 2046 ¶¶ 39–44). We did the same for the “information identifying . . . any and all medical doctors” language, concluding that: The specification does not suggest that failing to include on the prescription one or more pieces of information from the list of a “medical doctor’s name, license number, DEA number, and physician specialty,” as proposed by Patent Owner, means that a prescription fails to contain information regarding “various credentials,” as recited in the claims.” slip op. at 5
Claim constructioncites PhillipsPatents in suitUS 7,668,730 - PTAB · Dec 22, 2016 · IPR2015-00547 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied Jazz Pharmaceuticals’ rehearing request, leaving claims 1–6 unpatentable as obvious over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims.” slip op. at 5
Claim constructioncites PhillipsPatents in suitUS 7,765,107 - PTAB · Dec 22, 2016 · IPR2015-00551 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Jazz Pharmaceuticals’ rehearing request, leaving claims 1–15 unpatentable for obviousness over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“PO Resp. 60. We did not find such testimony persuasive, or particularly credible, in view of Korfhage’s express disclosures, Dr. Valuck’s testimony, and Dr. Bergeron’s deposition testimony. Dec. 57–59 (citing Ex. 1007 ¶ 157; Ex. 1037, 276–77; Ex. 1054, 317:13–320:12; Ex. 2047 ¶ 57–59). Patent Owner’s argument is not persuasive given that the ACA drug distribution system was designed to allow a pharmacist to identify and resolve duplicate prescriptions before deciding whether to distribute the drug to a patient (or delete a duplicate caused by data redundancy). Ex. 1003, 184:24–185:7; Ex. 1005, 314 ¶ 6. We also were persuaded by Dr. Valuck’s testimony that it would have been obvious for one of ordinary skill to modify the ACA system “such that the data stored in the central data repository was distributed across multiple databases, as disclosed by Korfhage in order to accommodate cost, efficiency, and the number of prescription requests and associated data.” Ex. 1007 ¶ 157 (cited at Dec. 57–581).” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“We also agree with Petitioner that Korfhage does not teach away from the use of distributed databases systems, particularly given the acknowledgement of Dr. Bergeron that Korfhage offered solutions to the problems identified. Id. at 59 (citing Ex. 1037, 276–77; Ex. 1054, 317:13–320:12). We did not overlook or misapprehend Patent Owner’s argument and evidence, rather, we declined to credit them in view of the text of Korfhage, Dr. Valuck’s testimony, and Dr. Bergeron’s deposition testimony. Dec. 56– 59. The pages of Korfhage cited and quoted in our Decision disclose multiple factors “driving information systems to the use of distributed document sets and distributed processing,” and set up “[t]hree major problems” only to discuss “simple solution[s],” a position supported by Dr. Valuck. Dec. 57–59 (citing Ex. 1007 ¶ 157; Ex. 1037 at 276–77). Under cross-examination by Petitioner’s counsel, Dr. Bergeron readily acknowledged that Korfhage’s discussion of data redundancy and matching document evaluation “problems” were paired with disclosed solutions, which undercut his declaration testimony (Ex. 2047 ¶¶ 56–65) relied upon by Patent Owner. Ex. 1054, 317:13–320:12. Our Decision credits Dr. Bergeron’s deposition testimony, which acknowledges the distributed database system solutions disclosed in Korfhage, rather than the speculative new problems hypothesized in his declaration and Patent Owner’s Response.” slip op. at 4
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state, and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims. Dec. 19 (emphasis added). We made clear that the controlling description of the specification outweighed Patent Owner’s argument and supporting evidence that specific types of information are required to be read into the “identifying” element of the claims. Id. (“Thus, we construe ‘prescription requests [for GHB] containing information identifying patients’ to refer to information identifying a patient, which may include [Patent Owner’s specifically listed information], but is not limited to that information nor requires all of that information.”) (emphasis added). We also cited to all of the expert testimony on which Patent Owner relied for its claim construction, as an indication that we considered the testimony. Id. at 18 (citing Ex. 2044, 97:11–98:5, 99:18–100:10; Ex. 2046 ¶¶ 39–44). We did the same for the “information identifying . . . any and all medical doctors” language, concluding that: The specification does not suggest that failing to include on the prescription one or more pieces of information from the list of a “medical doctor’s name, license number, DEA number, and physician specialty,” as proposed by Patent Owner, means that a prescription fails to contain information regarding “various credentials,” as recited in the claims. Id. at 20–21 (citing PO Resp. 33–36; Ex. 1001, 2:22–24, 2:41–42, 4:7–8, 4:8–14, 4:18–20, 4:20–22, 4:7–5:67, 8:4–7, 8:40–44, 10:20–23, Figs. 2A–C, 9; Ex. 2044, 181:1–23; Ex. 2046 ¶¶ 45–49). Though we did not discuss the expert testimony, we considered it. For example, on the same page of testimony cited by Patent Owner, Dr. Valuck testified that the information sufficient to identify a patient is “whatever the pharmacist believes is required to sufficiently identify the patient in their professional judgment.” Ex. 2044, 98:2–16. Even so, our Decision puts primary emphasis on the claim language and relevant description of the “identifying” element in the specification, not the extrinsic expert testimony relied upon by Patent Owner. See Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1012–13 (Fed. Cir. 2016) (“The legal part of claim construction is the determination of the meaning of the term in the claim in light of the patent’s intrinsic record.”); see also Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (stating that sources outside the specification should not be “used to contradict claim meaning that is unambiguous in light of the intrinsic evidence.”).” slip op. at 8
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 8,457,988 - PTAB · Dec 22, 2016 · IPR2015-00545 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Patent Owner’s rehearing request and reaffirmed that claims 19–25 are unpatentable as obvious over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Expert testimonyPatent owner expert discountedDecided for patent owner
“cite to Dr. Bergeron’s Declaration testimony in support. PO Resp. 26–29 (citing Ex. 2047 ¶¶ 27–30); Req. Reh’g 2–5 (citing Ex. 2047 ¶¶ 27–30). Although we did not cite to Dr. Bergeron’s Declaration testimony in our Decision regarding claims 19–25, we did consider Dr. Bergeron’s Declaration testimony. Dec. 2. Dr. Bergeron’s Declaration testimony simply restates Patent Owner’s Response arguments, including the argument that the ACA discloses “the verification is being done by a human, not a computer processor.” Ex. 2047 ¶ 28. We take this opportunity to make explicit that we are not persuaded by Dr. Bergeron’s cited Declaration testimony (Ex. 2047 ¶¶ 27–30) on the issue of whether the ACA discloses or suggests the “verifying” step in claim 19, for the same reasons given in our Decision and above.” slip op. at 7
NonePatents in suitUS 8,589,182 - PTAB · Dec 22, 2016 · IPR2015-00548 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–16 unpatentable as obvious over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims.” slip op. at 5
Claim constructioncites PhillipsPatents in suitUS 7,895,059 - PTAB · Dec 22, 2016 · IPR2015-00546 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–8 unpatentable as obvious over the Advisory Committee Art under § 103(a).
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims.” slip op. at 5
- Claim Construction › Extrinsic evidence (dictionaries, experts)Decided for petitioner
“Id. at 20–22 (citing PO Resp. 33–36; Ex. 1001, 2:28–30, 47–48, 4:13–6:4, 8:4–7, 40–44, 9:56–60, Figs. 2A–C, 9; Ex. 2044, 181:1–23; Ex. 2046 ¶¶ 45– 49). Though we did not discuss the expert testimony, we considered it. For example, on the same page of testimony cited by Patent Owner, Dr. Valuck testified that the information sufficient to identify a patient is “whatever the pharmacist believes is required to sufficiently identify the patient in their professional judgment.” Ex. 2044, 98:2–16. Even so, our Decision puts primary emphasis on the claim language and relevant description of the “identifying” element in the specification, not the extrinsic expert testimony relied upon by Patent Owner. See Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1012–13 (Fed. Cir. 2016) (“The legal part of claim construction is the determination of the meaning of the term in the claim in light of the patent’s intrinsic record.”); see also Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (stating that sources outside the specification should not be “used to contradict claim meaning that is unambiguous in light of the intrinsic evidence”).” slip op. at 6
Claim constructioncites PhillipsPatents in suitUS 7,765,106 - Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb CompanyNo claims unpatentablePTAB · Dec 22, 2016 · IPR2015-01537 · APJ Deborah Katz · IPR · Final written decision
Claims 1–15 were not shown unpatentable as obvious over Cohen, Shire, and Carpenter because Petitioner did not establish a reasonable expectation of success.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedOther
“suggests a trial-and-error approach to protein formulation. See Ex. 2011 (“Very often, proteins have to be evaluated individually and stabilized on a trial-and-error basis.”). Thus, we credit Dr. Staples’s testimony regarding the use of trial-and-error optimization because it appears that this was a known approach for formulating proteins. We do not agree that because the approach was known, it was necessarily expected to be successful. Petitioner cites to the statement in Carpenter that the authors were “quite confident” the generalized high throughput formulation procedure they describe “can be coupled successfully with high throughput screening strategies of protein drugs and facilitate drug development within the inherent time and resource constraints of the pharmaceutical industry.” Ex. 1004, 195. We note that, although in isolation Carpenter’s proclamation of being “quite confident” appears to demonstrate a reasonable expectation of success, when considered in context it refers to a general trend in the industry, not to the ability to formulate specific proteins. The full statement does not indicate that there was confidence that any particular drug could be successfully formulated as a liquid. Thus, this evidence is not persuasive.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation foundNot shown unpatentable
“parties, we determine, on balance, that Petitioner has not established sufficiently that an ordinary artisan would have had a reasonable expectation of success in formulating CTLA4Ig as a stable liquid formulation as recited in the challenged claims. Specifically, in the challenge to Patent Owner’s claims, Petitioner relies on Carpenter to show that an ordinarily skilled artisan would have known how to prepare a stable liquid formulation of CTLA4Ig for subcutaneous administration. Pet. 33–40. The statements in Carpenter are the most significant evidence of whether there would have been an expectation of success in achieving the claimed formulation. But Carpenter expressly states that “[i]t [could] be assumed that most proteins will not exhibit sufficient stability in aqueous solution to allow a liquid formulation to be developed.” Ex. 1004, 188; PO Resp. 16. Carpenter also states that although a stable liquid formulation is desirable, “for most proteins maintaining physical and chemical stabilities in aqueous solution for an extended period of time is extremely difficult.” Ex. 1004, 184. These statements indicate that there would not have been a reasonable expectation of success in achieving the claimed formulations. Dr. Staples’s testimony about routine trial-and-error optimization does not overcome these statements. Petitioner’s citation to Paborji (Ex. 1016) does not persuade us otherwise. Even though Paborji states that CTLA4Ig in phosphate buffer is “relatively stable,” without testimony to explain how this would be interpreted by a skilled artisan, the strong doubt about success expressed in Carpenter is not overcome.” slip op. at 13
Patent outcomesUS 8,476,239 not shown unpatentable§ 103 obviousnesscites KSRPatents in suitUS 8,476,239
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.